AN ORODISPERSIBLE PHARMACEUTICAL SOLID DOSAGE FORM OF RASAGILINE

    公开(公告)号:US20240115492A1

    公开(公告)日:2024-04-11

    申请号:US18262867

    申请日:2022-01-28

    摘要: The present invention relates to an orodispersible pharmaceutical solid dosage form comprising a therapeutically effective amount of rasagiline or a pharmaceutically acceptable salt thereof a pharmaceutically acceptable polymer suitable for forming a matrix with rasagiline or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients, wherein rasagiline or a pharmaceutically acceptable salt thereof is trapped within the matrix, and wherein said dosage form exhibits a dissolution profile according to which (i) after 2 minutes at pH=7.0, less than 12% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and (ii) after 15 minutes at pH=1.2, more than 75% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and (iii) after 40 minutes at pH=1.2, at least 90% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and wherein said orodispersible pharmaceutical solid dosage form is disintegrated in less than 3 minutes.

    STABLE LYOPHILIZED COMPOSITION OF CYCLOPHOSPHAMIDE

    公开(公告)号:US20210100821A1

    公开(公告)日:2021-04-08

    申请号:US16971179

    申请日:2019-02-26

    IPC分类号: A61K31/675 A61K9/19 A61K47/26

    摘要: This present invention relates to a stable lyophilized composition of Cyclophosphamide. The said stable lyophilized composition of Cyclophosphamide provides an improved moisture content than the lyophilized Cyclophosphamide compositions obtained by the conventional lyophilization method. Further, the invention relates to a process for preparation of the said stable lyophilized composition of Cyclophosphamide, wherein the said process comprises controlled lyophilization with freezing and annealing at a temperature above 0° C.